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Prevention study for Bronchopulmonary Dysplasia
Official title Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
ClinicalTrials.gov ID: NCT03631420
What this study is testing
What is Human Umbilical Cord Derived-Mesenchymal Stem Cells?
Human Umbilical Cord Derived-Mesenchymal Stem Cells is an investigational medicine, being studied as a potential treatment for bronchopulmonary dysplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 51
You may be able to join if
- Neonatal infants who fulfil all of the following criteria will be enrolled:
- people of postnatal age between 3 to 30 days.
- Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36...
- people with birth weight between 501g to 1249 g.
- Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not...
You likely can't join if
- Neonatal infants who meet any of the following criteria will be excluded:
- Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular...
- Have a known genetic syndrome.
- Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
- Have C-reactive protein (CRP) \>30 mg/L; or any infections including pneumonia, sepsis, or shock.
- Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
See the full eligibility criteria
- Neonatal infants who fulfil all of the following criteria will be enrolled:
- people of postnatal age between 3 to 30 days.
- Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks.
- people with birth weight between 501g to 1249 g.
- Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study.
- A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
- A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
- Written informed consent has been provided by the subject's parents, legal guardians, or a legal representative, who agree to comply with all of the study procedures, including those in the long-term safety surveillance...
- Neonatal infants who meet any of the following criteria will be excluded:
- Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
- Have a known genetic syndrome.
- Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
- Have C-reactive protein (CRP) \>30 mg/L; or any infections including pneumonia, sepsis, or shock.
- Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
- Have active pulmonary hemorrhage or air leak syndrome.
- Have abnormal hepatic (AST, ALT \>150 U/L or direct bilirubin \>2 mg/dL or total bilirubin \>15 mg/dL) or renal function (serum creatinine \>1 mg/dL or oliguria).
- Are known to be infected with HIV or CMV.
- Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation.
- Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation.
- Are currently participating in any other treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Tainan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 days to 51 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tainan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.